U.S. patent application number 11/434130 was filed with the patent office on 2006-11-16 for systems and methods to facilitate endoscopic.
Invention is credited to Kenneth F. Binmoeller.
Application Number | 20060258906 11/434130 |
Document ID | / |
Family ID | 37432026 |
Filed Date | 2006-11-16 |
United States Patent
Application |
20060258906 |
Kind Code |
A1 |
Binmoeller; Kenneth F. |
November 16, 2006 |
Systems and methods to facilitate endoscopic
Abstract
Disclosed herein are devices, systems and methods for use with
endoscopic instruments. More specifically, the presently described
devices, systems and methods utilize overtube devices for use with
endoscopic instruments that allow more diagnostic and therapeutic
interventions than previously possible.
Inventors: |
Binmoeller; Kenneth F.;
(Rancho Santa Fe, CA) |
Correspondence
Address: |
PRESTON GATES ELLIS & ROUVELAS MEEDS LLP
1735 NEW YORK AVENUE, NW, SUITE 500
WASHINGTON
DC
20006
US
|
Family ID: |
37432026 |
Appl. No.: |
11/434130 |
Filed: |
May 16, 2006 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60681014 |
May 16, 2005 |
|
|
|
Current U.S.
Class: |
600/114 ;
600/121 |
Current CPC
Class: |
A61B 1/00135 20130101;
A61B 1/012 20130101; A61B 1/018 20130101 |
Class at
Publication: |
600/114 ;
600/121 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1. A device comprising a flexible tube and one or more open
channels within the wall of said flexible tube wherein said tube
further comprises a break along its length and the inner
circumference of said tube is within about 0.5 mm of the outer
perimeter of an endoscope and wherein said flexible tube is
introduced onto said endoscope with the use of an introducer.
2. The device according to claim 1 wherein said one or more open
channels within said wall of said flexible tube extend the length
of said tube.
3. The device according to claim 1 wherein said lengthwise break
can be closed.
4. An endoscope comprising an introducer for use with a device
according to claim 1.
5. The device according to claim 1 wherein said one or more open
channels are collapsed in their free state.
6. The device according to claim 1 wherein said flexible tube is
segmented along its length with sections of semi-rigid and flexible
materials.
7. The device according to claim 6 wherein said sections of
semi-rigid and flexible materials alternate along said length of
said flexible tube.
8. The device according to claim 1 wherein said device further
comprises a clamp mechanism at or near the proximal end of said
flexible tube.
9. The device according to claim 1 wherein one or more of said open
channels house a control wire that terminates proximally in a
control device.
10. The device according to claim 9 wherein the distal end of said
control wire comprises one or more hooks.
11. The device according to claim 1 wherein one end and a portion
of said flexible tube adjacent thereto have a perimeter that is
reduced compared to the rest of said flexible tube.
12. The device according to claim 11 wherein said reduced perimeter
portion of said flexible tube comprises one or more lugs.
13. A system comprising a first device comprising a flexible tube
and one or more open channels within the wall of said flexible tube
wherein said tube further comprises a break along its length and
the inner circumference of said tube is within about 0.5 mm of the
outer perimeter of an endoscope and a second device wherein said
second device comprises a tube with an inner circumference of
within about 0.5 mm of said outer perimeter of said endoscope.
14. The system according to claim 13 wherein said one or more open
channels within said wall of said first device extend the length of
said first device.
15. The system according to claim 13 wherein said lengthwise break
of said first device can be closed.
16. An endoscope comprising an introducer for use with a system
according to claim 13.
17. The system according to claim 13 wherein said one or more open
channels within said wall of said first device are collapsed in
their free state.
18. The system according to claim 13 wherein said flexible tube of
said first device is segmented along its length with sections of
semi-rigid and flexible materials.
19. The system according to claim 18 wherein said sections of
semi-rigid and flexible materials alternate along said length of
said flexible tube of said first device.
20. The system according to claim 13 wherein said first device
further comprises a clamp mechanism at or near its proximal
end.
21. The system according to claim 13 wherein one or more of said
open channels within said wall of said first device house a control
wire that terminates proximally in a control device.
22. The system according to claim 21 wherein the distal end of said
control wire comprises one or more hooks.
23. The system according to claim 22 wherein said first device and
said second device can be linked.
24. The system according to claim 23 wherein on said first device,
one end and a portion of said first device adjacent thereto have a
perimeter that is reduced compared to the rest of said first
device.
25. The system according to claim 24 wherein said reduced perimeter
portion of said first device fits within the perimeter of said
second device.
26. The system according to claim 25 wherein said reduced perimeter
portion of said first device further comprises one or more lugs and
one end and a portion adjacent thereto of said second device
comprise one or more slots configured to receive said one or more
lugs.
27. The system according to claim 26 wherein said one or more lugs
and said one or more slots can securely link said first device and
said second device.
28. The system according to claim 27 wherein said link is in the
form of a bayonet joint.
29. The system according to claim 23 wherein said second device
comprises an actuator member.
30. The system according to claim 26 wherein said second device
comprises an actuator that comprises an eyelet and wherein when
said first device and said second device are linked, said hook of
said wire engages said eyelet of said actuator member and said wire
can be used to control said second device.
31. The system according to claim 13 wherein said second device is
adapted to perform a function selected from the group consisting of
providing a space to adjust the distance of the endoscope tip to
tissue, detecting changes in tissue, providing a space to aspirate
and hold tissue, providing a medium to enhance optics, deploying a
stent, deploying a ligating element, deploying a cutting instrument
with diathermy, deploying a cutting instrument without diathermy,
deploying an anchoring element, deploying a joining element, and
deploying tissue ablative energy.
32. A device comprising a tubular portion with an inner perimeter
of within about 0.5 mm of the outer perimeter of an endoscope
wherein said device comprises an actuator.
33. The device according to claim 32 wherein said actuator
comprises an eyelet.
34. The device according to claim 32 wherein said device is adapted
to perform a function near the end of an endoscope selected from
the group consisting of providing a space to adjust the distance of
the endoscope tip to tissue, detecting changes in tissue, providing
a space to aspirate and hold tissue, providing a medium to enhance
optics, deploying a stent, deploying a ligating element, deploying
a cutting instrument with diathermy, deploying a cutting instrument
without diathermy, deploying an anchoring element, deploying a
joining element, and deploying tissue ablative energy.
35. A method comprising: performing an endoscopic procedure on a
patient with an endoscope, wherein said endoscope is associated
with an overtube, wherein said overtube comprises a flexible tube
and one or more open channels within the wall of said flexible tube
wherein said overtube further comprises a break along its length
and the inner circumference of said overtube is within about 0.5 mm
of the outer perimeter of said endoscope and wherein said overtube
is introduced onto said endoscope with the use of an
introducer.
36. The method according to claim 35 wherein said one or more open
channels within said wall of said flexible tube extend the length
of said tube.
37. The method according to claim 35 wherein said lengthwise break
can be closed.
38. The method according to claim 35 wherein said endoscope
comprises said introducer.
39. The method according to claim 35 wherein said one or more open
channels are collapsed in their free state.
40. The method according to claim 35 wherein said overtube is
segmented along its length with sections of semi-rigid and flexible
materials.
41. The method according to claim 40 wherein said sections of
semi-rigid and flexible materials alternate along said length of
said overtube.
42. The method according to claim 35 wherein said overtube further
comprises a clamp mechanism at or near its proximal end.
43. The method according to claim 35 wherein one or more of said
open channels house a control wire that terminates proximally in a
control device operated by a person involved in the performing of
said endoscopic procedure.
44. The method according to claim 43 wherein the distal end of said
control wire comprises one or more hooks.
45. The method according to claim 35 wherein one end and a portion
of said overtube adjacent thereto have a perimeter that is reduced
compared to the rest of said overtube.
46. The method according to claim 45 wherein said reduced perimeter
portion of said overtube comprises one or more lugs.
47. The method according to claim 35 wherein said performing of
said endoscopic procedure further comprises associating a
pre-placed device with said endoscope wherein said pre-placed
device comprises a tube with an inner circumference of within about
0.5 mm of said outer perimeter of said endoscope and said
associating occurs through placing said pre-placed device around
said outer perimeter of said endoscope.
48. The method according to claim 47 wherein said performing of
said endoscopic procedure further comprises linking said overtube
and said pre-placed device.
49. The method according to claim 48 wherein one or more of said
open channels house a control wire that terminates proximally in a
control device operated by a person involved in the performing of
said endoscopic procedure.
50. The method according to claim 49 wherein the distal end of said
control wire comprises one or more hooks.
51. The method according to claim 50 wherein said linking occurs
through the use of one or more lugs and one or more slots to form a
bayonet joint.
52. The method according to claim 47 wherein said pre-placed device
comprises an actuator member.
53. The method according to claim 50 wherein said pre-placed device
comprises an actuator that comprises an eyelet and wherein when
said overtube and said pre-placed device are linked, said hook of
said wire engages said eyelet of said actuator member and said wire
can be used to control said pre-placed device.
54. The method according to claim 47 wherein one aspect of said
endoscopic procedure comprises using said pre-placed device to
perform a function selected from the group consisting of providing
a space to adjust the distance of the endoscope tip to tissue,
detecting changes in tissue, providing a space to aspirate and hold
tissue, providing a medium to enhance optics, deploying a stent,
deploying a ligating element, deploying a cutting instrument with
diathermy, deploying a cutting instrument without diathermy,
deploying an anchoring element, deploying a joining element, and
deploying tissue ablative energy.
55. A method comprising: assembling an endoscopic device wherein
said endoscopic device comprises an endoscope and an overtube,
wherein said overtube comprises a flexible tube and one or more
open channels within the wall of said flexible tube wherein said
tube further comprises a break along its length and the inner
circumference of said tube is within about 0.5 mm of the outer
perimeter of said endoscope and wherein said assembling comprises
placing said overtube around the outer perimeter of said endoscope
with the use of an introducer.
56. The method according to claim 55 wherein said one or more open
channels within said wall of said flexible tube extend the length
of said tube.
57. The method according to claim 55 wherein said lengthwise break
can be closed.
58. The method according to claim 55 wherein said endoscope
comprises an introducer for use in said placing of said
overtube.
59. The method according to claim 55 wherein said one or more open
channels are collapsed in their free state.
60. The method according to claim 55 wherein said flexible tube is
segmented along its length with sections of semi-rigid and flexible
materials.
61. The method according to claim 60 wherein said sections of
semi-rigid and flexible materials alternate along said length of
said flexible tube.
62. The method according to claim 55 wherein said overtube further
comprises a clamp mechanism at or near its proximal end and said
method further comprises clamping said mechanism after said
placing.
63. The method according to claim 55 wherein one or more of said
open channels house a control wire that terminates proximally in a
control device.
64. The method according to claim 63 wherein the distal end of said
control wire comprises one or more hooks.
65. The method according to claim 55 wherein said assembling
further comprises associating said endoscope of said endoscopic
device with a pre-placed device, said pre-placed device comprising
a tube with an inner circumference of within about 0.5 mm of said
outer perimeter of said endoscope and wherein said associating
comprises placing said pre-placed device around said outer
perimeter of said endoscope.
66. The method according to claim 65 wherein said method further
comprises linking said overtube and said pre-placed device.
67. The method according to claim 65 wherein one or more of said
open channels house a control wire that terminates proximally in a
control device.
68. The method according to claim 67 wherein the distal end of said
control wire comprises one or more hooks.
69. The method according to claim 66 wherein said linking occurs
through the use of a bayonet joint using one or more lugs on said
overtube and one or more slots on said pre-placed device.
70. The method according to claim 65 wherein said pre-placed device
comprises an actuator member.
71. The method according to claim 68 wherein said pre-placed device
comprises an actuator that comprises an eyelet and wherein when
said overtube and said pre-placed device are linked, said hook of
said wire engages said eyelet of said actuator member and said wire
can be used to control said pre-placed device.
72. The method according to claim 65 wherein said pre-placed device
is adapted to perform a function selected from the group consisting
of providing a space to adjust the distance of the endoscope tip to
tissue, detecting changes in tissue, providing a space to aspirate
and hold tissue, providing a medium to enhance optics, deploying a
stent, deploying a ligating element, deploying a cutting instrument
with diathermy, deploying a cutting instrument without diathermy,
deploying an anchoring element, deploying a joining element, and
deploying tissue ablative energy.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority under 35 U.S.C. .sctn. 119
to U.S. Provisional Patent Application Ser. No. 60/681,014, filed
on May 16, 2005, the entire contents of which are expressly
incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The devices, systems and methods described herein relate to
the field of endoscopic instruments. More specifically, the
devices, systems and methods described herein utilize overtube
devices with novel features for use with endoscopic instruments
that allow for more diagnostic and therapeutic interventions than
previously possible.
BACKGROUND OF THE INVENTION
[0003] Less invasive surgical procedures can reduce patient trauma
and, as a result, may reduce the length of hospital stays, as well
as hospital and medical costs. Endoscopic surgery recently has
provided a significant opportunity to reduce the invasiveness of
numerous surgical procedures. This type of surgery involves the use
of an endoscope, an instrument that permits the visual inspection
and magnification of cavities within the body. An endoscope may be
inserted through a small surgical incision to view organ structures
in a body cavity or through a natural orifice such as the mouth,
anus, bladder, and vagina to view channel-containing organs in the
gastrointestinal, respiratory, and genital and urinary tracts.
Endoscopes generally have channels along their length to introduce
instrumentation for functions such as irrigation or suction, and
for the insertion of accessory instruments when a surgical
procedure is performed. While endoscopes provide a number of
advantages, presently available diagnostic and therapeutic
interventions are restricted by the dimension of an endoscope's
working channel that permit only a limited number of instruments to
be advanced to a treatment site at a time. While some endoscope
accessory devices provide sheaths with additional channels for
instrumentation, these devices have certain restrictions (such as a
requirement to be placed around the endoscope prior to insertion
into a patient) and do not allow for control over a variety of
additional tools that may be found at the end of an endoscope.
Thus, an advance that allowed for additional diagnostic and
therapeutic interventions through the use of endoscopes by allowing
the introduction of more instruments at a treatment site, without
the restrictions associated with previous devices, would provide a
great benefit. The present invention provides such an advance.
SUMMARY OF THE INVENTION
[0004] The present invention provides devices, systems and methods
to increase the potential number of diagnostic and therapeutic
interventions performed through endoscopes without the restrictions
associated with previous devices. The present invention increases
the potential for diagnostic and therapeutic interventions by
providing access channels outside the normal working channel of an
endoscope that, in one embodiment, can be introduced after the
endoscope has been inserted into a patient. These access channels
are provided in devices presently called overtubes that fit around
a conventional endoscope. The overtubes of the present invention
can include one or more additional channels through which
instrumentation can be deployed, increasing the number of tools
that can be concurrently used at a treatment site with the
deployment of one endoscope. Further, overtubes of the present
invention can be used in conjunction with devices that are
pre-placed around an endoscope ("pre-placed devices"). Pre-placed
devices can be used to perform a number of functions that enhance
diagnostic and therapeutic objectives outside the conventional
channel of an endoscope. Some of these functions can include,
without limitation, providing a space to adjust the distance of the
endoscope tip to tissue, detecting changes in tissue (including,
without limitation macro- and or microstructural, biochemical or
molecular changes), providing a space to aspirate and hold tissue,
providing a medium to enhance optics, deploying a stent, deploying
a ligating element (including, without limitation a band or a
loop), deploying a cutting instrument (including, without
limitation, a snare or a needle knife) with diathermy, deploying a
cutting instrument without diathermy, deploying an anchoring or
joining element (including, without limitation, a stitch, staple,
or T-tag), and deploying tissue ablative energy (including, without
limitation, thermal, photochemical, laser, microwave and
radiofrequency).
[0005] Specifically, one embodiment according to the present
invention is a device comprising a flexible tube and one or more
open channels within the wall of the flexible tube wherein the tube
further comprises a break along its length and the inner
circumference of the tube is within about 0.5 mm of the outer
perimeter of an endoscope and wherein the flexible tube is
introduced onto the endoscope with the use of an introducer.
[0006] In another embodiment of the device, the one or more open
channels within the wall of the flexible tube extend the length of
the tube. In another embodiment of the device, the lengthwise break
can be closed. In another embodiment of the device, the one or more
open channels are collapsed in their free state. In another
embodiment of the device, the flexible tube is segmented along its
length with sections of semi-rigid and flexible materials. In
another embodiment of the device, the sections of semi-rigid and
flexible materials alternate along the length of the flexible tube.
In another embodiment of the device, the device further comprises a
clamp mechanism at or near the proximal end of the flexible tube.
In another embodiment of the device, the one or more of the open
channels house a control wire that terminates proximally in a
control device. In another embodiment of the device, the distal end
of the control wire comprises one or more hooks. In another
embodiment of the device, one end and a portion of the flexible
tube adjacent thereto have a perimeter that is reduced compared to
the rest of the flexible tube. In another embodiment of the device,
the reduced perimeter portion of the flexible tube comprises one or
more lugs.
[0007] Another embodiment of the present invention comprises an
endoscope with an introducer for use with one of the devices of the
present invention.
[0008] The present invention also comprises systems. In one
embodiment of the systems according to the present invention, the
system comprises a first device comprising a flexible tube and one
or more open channels within the wall of the flexible tube wherein
the tube further comprises a break along its length and the inner
circumference of the tube is within about 0.5 mm of the outer
perimeter of an endoscope and a second device wherein the second
device comprises a tube with an inner circumference of within about
0.5 mm of the outer perimeter of the endoscope.
[0009] In another embodiment of the systems, the one or more open
channels within the wall of the first device extend the length of
the first device. In another embodiment of the systems, the
lengthwise break of the first device can be closed. In another
embodiment of the systems, the one or more open channels within the
wall of the first device are collapsed in their free state. In
another embodiment of the systems, the flexible tube of the first
device is segmented along its length with sections of semi-rigid
and flexible materials. In another embodiment of the systems, the
sections of semi-rigid and flexible materials alternate along the
length of the flexible tube of the first device. In another
embodiment of the systems, the first device further comprises a
clamp mechanism at or near its proximal end. In another embodiment
of the systems, the one or more of the open channels within the
wall of the first device house a control wire that terminates
proximally in a control device. In another embodiment of the
systems, the distal end of the control wire comprises one or more
hooks. In another embodiment of the systems, the first device and
the second device can be linked. In another embodiment of the
systems, on the first device, one end and a portion of the first
device adjacent thereto have a perimeter that is reduced compared
to the rest of the first device. In another embodiment of the
systems, the reduced perimeter portion of the first device fits
within the perimeter of the second device. In another embodiment of
the systems, the reduced perimeter portion of the first device
further comprises one or more lugs and one end and a portion
adjacent thereto of the second device comprise one or more slots
configured to receive the one or more lugs. In another embodiment
of the systems, the one or more lugs and the one or more slots can
securely link the first device and the second device. In another
embodiment of the systems, the link is in the form of a bayonet
joint. In another embodiment of the systems, the second device
comprises an actuator member. In another embodiment of the systems,
the second device comprises an actuator that comprises an eyelet
and wherein when the first device and the second device are linked,
the hook of the wire engages the eyelet of the actuator member and
the wire can be used to control the second device. In another
embodiment of the systems, the second device is adapted to perform
a function selected from the group consisting of providing a space
to adjust the distance of the endoscope tip to tissue, detecting
changes in tissue (including, without limitation macro- and or
microstructural, biochemical or molecular changes), providing a
space to aspirate and hold tissue, providing a medium to enhance
optics, deploying a stent, deploying a ligating element (including,
without limitation a band or a loop), deploying a cutting
instrument (including, without limitation, a snare or a needle
knife) with diathermy, deploying a cutting instrument without
diathermy, deploying an anchoring or joining element (including,
without limitation, a stitch, staple, or T-tag), and deploying
tissue ablative energy (including, without limitation, thermal,
photochemical, laser, microwave and radiofrequency).
[0010] The present invention also includes an endoscope comprising
an introducer for use with the systems of the present
invention.
[0011] In one embodiment according to the present invention, the
invention further comprises a device comprising a tubular portion
with an inner perimeter of within about 0.5 mm of the outer
perimeter of an endoscope wherein the device comprises an actuator.
In another embodiment of the device, the actuator comprises an
eyelet. In another embodiment of the device, the device is adapted
to perform a function near the end of an endoscope selected from
the group consisting of providing a space to adjust the distance of
the endoscope tip to tissue, detecting changes in tissue
(including, without limitation macro- and or microstructural,
biochemical or molecular changes), providing a space to aspirate
and hold tissue, providing a medium to enhance optics, deploying a
stent, deploying a ligating element (including, without limitation
a band or a loop), deploying a cutting instrument (including,
without limitation, a snare or a needle knife) with diathermy,
deploying a cutting instrument without diathermy, deploying an
anchoring or joining element (including, without limitation, a
stitch, staple, or T-tag), and deploying tissue ablative energy
(including, without limitation, thermal, photochemical, laser,
microwave and radiofrequency).
[0012] The present invention also comprises methods. In one method
according to the present invention, the method comprises performing
an endoscopic procedure on a patient with an endoscope, wherein the
endoscope is associated with an overtube, wherein the overtube
comprises a flexible tube and one or more open channels within the
wall of the flexible tube wherein the tube further comprises a
break along its length and the inner circumference of the tube is
within about 0.5 mm of the outer perimeter of the endoscope and
wherein the overtube is introduced onto the endoscope with the use
of an introducer.
[0013] In another embodiment of the methods, the one or more open
channels within the wall of the flexible tube extend the length of
the tube. In another embodiment of the methods, the lengthwise
break can be closed. In another embodiment of the methods, the
endoscope comprises an introducer. In another embodiment of the
methods, the one or more open channels are collapsed in their free
state. In another embodiment of the methods, the overtube is
segmented along its length with sections of semi-rigid and flexible
materials. In another embodiment of the methods, the semi-rigid and
flexible materials alternate along the length of the overtube. In
another embodiment of the methods, the overtube further comprises a
clamp mechanism at or near its proximal end. In another embodiment
of the methods, the one or more of the open channels house a
control wire that terminates proximally in a control device
operated by a person involved in the performing of the endoscopic
procedure. In another embodiment of the methods, the distal end of
the control wire comprises one or more hooks. In another embodiment
of the methods, one end and a portion of the overtube adjacent
thereto have a perimeter that is reduced compared to the rest of
the overtube. In another embodiment of the methods, the reduced
perimeter portion of the overtube comprises one or more lugs.
[0014] In another embodiment of the methods, the performing of the
endoscopic procedure further comprises associating a pre-placed
device with the endoscope wherein the pre-placed device comprises a
tube with an inner circumference of within about 0.5 mm of the
outer perimeter of the endoscope and the associating occurs through
placing the pre-placed device around the outer perimeter of the
endoscope. In another embodiment of the methods, the performing of
the endoscopic procedure further comprises linking the overtube and
the pre-placed device. In another embodiment of the methods, the
one or more of the open channels house a control wire that
terminates proximally in a control device operated by a person
involved in the performing of the endoscopic procedure. In another
embodiment of the methods, the distal end of the control wire
comprises one or more hooks. In another embodiment of the methods,
the linking occurs through the use of on or more lugs and one or
more slots to form a bayonet joint. In another embodiment of the
methods, the pre-placed device comprises an actuator member. In
another embodiment of the methods, the pre-placed device comprises
an actuator that comprises an eyelet and wherein when the overtube
and the pre-placed device are linked, the hook of the wire engages
the eyelet of the actuator member and the wire can be used to
control the pre-placed device. In another embodiment of the
methods, one aspect of the endoscopic procedure comprises using the
pre-placed device to perform a function selected from the group
consisting of providing a space to adjust the distance of the
endoscope tip to tissue, detecting changes in tissue (including,
without limitation macro- and or microstructural, biochemical or
molecular changes), providing a space to aspirate and hold tissue,
providing a medium to enhance optics, deploying a stent, deploying
a ligating element (including, without limitation a band or a
loop), deploying a cutting instrument (including, without
limitation, a snare or a needle knife) with diathermy, deploying a
cutting instrument without diathermy, deploying an anchoring or
joining element (including, without limitation, a stitch, staple,
or T-tag), and deploying tissue ablative energy (including, without
limitation, thermal, photochemical, laser, microwave and
radiofrequency).
[0015] Another method according to the present invention comprises
assembling an endoscopic device wherein the endoscopic device
comprises an endoscope and an overtube, wherein the overtube
comprises a flexible tube and one or more open channels within the
wall of the flexible tube wherein the tube further comprises a
break along its length and the inner circumference of the tube is
within about 0.5 mm of the outer perimeter of the endoscope and
wherein the assembling comprises placing the overtube around the
outer perimeter of the endoscope with the use of an introducer.
[0016] In another assembling method, the one or more open channels
within the wall of the flexible tube extend the length of the tube.
In another assembling method, the lengthwise break can be closed.
In another assembling method, the endoscope comprises an introducer
for use in the placing of the overtube. In another assembling
method, the one or more open channels are collapsed in their free
state. In another assembling method, the flexible tube is segmented
along its length with sections of semi-rigid and flexible
materials. In another assembling method, the sections of semi-rigid
and flexible materials alternate along the length of the flexible
tube. In another assembling method, the overtube further comprises
a clamp mechanism at or near its proximal end and the method
further comprises clamping the mechanism after the placing. In
another assembling method, the one or more of the open channels
house a control wire that terminates proximally in a control
device. In another assembling method, the distal end of the control
wire comprises one or more hooks.
[0017] In another assembling method, the assembling further
comprises associating the endoscope of the endoscopic device with a
pre-placed device, the pre-placed device comprising a tube with an
inner circumference of within about 0.5 mm of the outer perimeter
of the endoscope and wherein the associating comprises placing the
pre-placed device around the outer perimeter of the endoscope. In
another assembling method, the method further comprises linking the
overtube and the pre-placed device. In another assembling method,
the one or more of the open channels house a control wire that
terminates proximally in a control device. In another assembling
method, the distal end of the control wire comprises one or more
hooks. In another assembling method, the linking occurs through the
use of a bayonet joint using one or more lugs on the overtube and
one or more slots on the pre-placed device. In another assembling
method, the pre-placed device comprises an actuator member. In
another assembling method, the pre-placed device comprises an
actuator that comprises an eyelet and wherein when the overtube and
the pre-placed device are linked, the hook of the wire engages the
eyelet of the actuator member and the wire can be used to control
the pre-placed device. In another assembling method, the pre-placed
device is adapted to perform a function selected from the group
consisting of providing a space to adjust the distance of the
endoscope tip to tissue, detecting changes in tissue (including,
without limitation macro- and or microstructural, biochemical or
molecular changes), providing a space to aspirate and hold tissue,
providing a medium to enhance optics, deploying a stent, deploying
a ligating element (including, without limitation a band or a
loop), deploying a cutting instrument (including, without
limitation, a snare or a needle knife) with diathermy, deploying a
cutting instrument without diathermy, deploying an anchoring or
joining element (including, without limitation, a stitch, staple,
or T-tag), and deploying tissue ablative energy (including, without
limitation, thermal, photochemical, laser, microwave and
radiofrequency).
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a perspective view of a typical flexible endoscope
known in the art;
[0019] FIG. 2 is a perspective view of one embodiment of an
overtube of the present invention in position to be installed
around a flexible endoscope;
[0020] FIG. 3 is a perspective view of an overtube according to the
present invention in its installed position around a flexible
endoscope;
[0021] FIG. 4 is a cross-sectional view of one embodiment of an
overtube according to the present invention;
[0022] FIG. 5 is a cross-sectional view of an alternative
embodiment of an overtube;
[0023] FIG. 6 is a cross-sectional view of the overtube depicted in
FIG. 5 with the open channels expanded by the insertion of
devices;
[0024] FIG. 7 is a cross-sectional view of an overtube with a
zip-lock type joint;
[0025] FIG. 8 is a detail of the zip-lock type joint depicted in
FIG. 7;
[0026] FIG. 9 is a perspective view of the distal end of an
overtube with filler sections removed for illustrative
purposes;
[0027] FIG. 10 is a perspective view, similar to FIG. 9, showing
the complete overtube with filler sections in place;
[0028] FIG. 11 is a perspective view of an introducer used to ease
the installation of an overtube onto the shaft of a flexible
endoscope;
[0029] FIGS. 12 and 13 show perspective views of the proximal end
of an overtube with a clamping mechanism;
[0030] FIG. 14 shows, in a series of three views (14a, 14b and 14c,
respectively), the sequence of steps in connecting a bayonet joint
between an overtube and a device pre-placed onto an endoscope
shaft;
[0031] FIG. 15a shows a detailed perspective view of the distal end
of an overtube with provision for a bayonet joint;
[0032] FIG. 15b shows an end view of the overtube depicted in FIG.
15a;
[0033] FIG. 16 depicts a cross-sectional view of the overtube shown
in FIG. 15b;
[0034] FIG. 17a is an end view of the assembly of the pre-placed
device and overtube depicted in FIG. 14c;
[0035] FIG. 17b is a cross-sectional view of a portion of the
assembly depicted in FIGS. 14c and 17a detailing the connection of
control wires and actuator members between the pre-placed device
and the overtube;
[0036] FIG. 18, consisting of FIGS. 18a and 18b, shows an
embodiment of a pre-placed cap device connected to an overtube with
a bayonet joint;
[0037] FIG. 19 shows, in a series of three views (FIGS. 19a, 19b
and 19c, respectively), a sequence of steps for using a pre-placed
band ligating device; and
[0038] FIG. 20 shows, in a series of three views (FIGS. 20a, 20b
and 20c, respectively), a sequence of steps for using a pre-placed
stent delivery device.
DETAILED DESCRIPTION OF THE INVENTION
[0039] Unless defined otherwise, all technical and scientific terms
used herein have the same meanings as commonly understood by one of
ordinary skill in the art to which this invention belongs. Specific
methods, devices, and materials are described, although any methods
and materials similar or equivalent to those described herein can
be used in the practice or testing of the present invention.
[0040] In the following description it should be noted that
directional terms such as "distal" and "proximal" are used relative
to each other and do not refer to positions or orientations
relative to an external frame of reference. Also, "locked" and
"interlocked" are coextensive in meaning.
[0041] The terms "endoscope" or "endoscopic" refer not only to
conventional endoscopes and endoscopic procedures, but also to any
rigid, semi-rigid, or flexible optical instrument for use in visual
examinations where access is limited to a small incision or
opening. Generally, such examinations will occur in the human body,
however, the use of the terms is not so restricted. References to
endoscopes and endoscopic procedures are understood also to
encompass procedures in all organisms, living or dead, as well as,
the examination of inanimate objects through small openings.
Endoscopes and endoscopic procedures are understood to include
laparoscopic devices and laproscopic procedures. The term
"endoscope" also includes echo-endoscopes, which may include an
ultrasound transducer at, for example, the tip of the device.
[0042] FIG. 1 through FIG. 20 depict exemplary devices, systems and
methods of the present invention. These devices, systems and
methods are depicted and described herein in order to better
explain the invention. It will be understood that the devices,
systems and methods shown are representative only, and that devices
of other configurations, sizes and styles are within the scope of
the present invention.
[0043] FIG. 1 is a perspective view of a flexible endoscope 1 as
known in the prior art. The endoscope has a distal end 5 that is
inserted into a body cavity of a human or animal. The distal end of
the endoscope is equipped with means for illuminating and viewing
inside the body cavity. The endoscope is typically fitted with a
channel for the insertion of various tools into the body. The end
of this channel is also located at the distal end of the endoscope.
The endoscope has a proximal end 10 that includes controls for
flexing the distal end of the endoscope among others controlling
function.
[0044] FIG. 2 is a perspective view of a flexible endoscope 1 and a
section of an overtube 20 in accordance with one embodiment of the
present invention. The section of overtube 20 is shown in position
ready to be installed around the endoscope. In this embodiment, an
introducer 15 is attached to the endoscope in order to aid in the
installation of the overtube 20. This feature will be described in
more detail in relation to FIG. 11. In one embodiment of the
present invention, the overtube 20 is installed around the
endoscope after the endoscope has been placed into the body cavity
at an approximate area of interest.
[0045] FIG. 3 is a perspective view of a flexible endoscope 1 with
an overtube 20 fully attached around the endoscope 1. In the
depicted embodiment, a clamp 25 serves to hold the overtube 20 in
position relative to the endoscope 1. Operation of the clamp will
be described in more detail in relation to FIGS. 12 and 13.
[0046] FIG. 4 depicts a cross-section taken normal to the long axis
of an overtube 20. The wall 30 of the overtube 20 encompasses
channels 45, 50 and 55. The number and size of channels included in
a particular overtube are variable and can be a function of the
overtube's intended usage and can include one or more, two or more,
three or more, four or more, or five or more channels. These
channels add extra functionality to the flexible endoscope by
allowing the delivery of additional instrumentation to an area of
interest. The ability to deliver additional instrumentation with
the insertion of one endoscope can increase the number of possible
interventions. The inner surface 35 of the overtube can be sized to
provide a close fit to the endoscope in use, such that it is large
enough not to bind the endoscope but small enough to be effectively
guided by the endoscope. In a specific embodiment, the depicted
break 40 in the overtube wall 30 allows the overtube 20 to be
installed over the proximal end of an endoscope while the distal
end of the endoscope is within a body cavity. Generally, the break
40 may run the entire length of the overtube 20. In practice, the
overtube 20 can be elastically deformed by the bending of its wall
30 to open the break 40 to a size that allows the endoscope to pass
inside the overtube 20. This elastic deformation may extend over
only a relatively small axial length of the overtube 20, and
progresses over the length of the overtube 20 as it is installed
around an endoscope. This deformation can be aided by an introducer
15, again to be described in more detail in relation to FIG.
11.
[0047] FIG. 5 depicts a cross-section taken normal to the long axis
of another embodiment of an overtube 60 according to the present
invention. This overtube 60 has two channels 65 that are
"collapsed" or highly elongated in their free state. In this
embodiment with collapsed channels, the outside perimeter of the
overtube 60 is reduced compared to the outside perimeter of the
overtube 20 depicted in FIG. 4. This smaller outside perimeter can
aid in the insertion of an overtube into a body cavity by reducing
the magnitude of the "step-off" or distance between the perimeter
of the endoscope shaft and the perimeter of the overtube. The
channels 65 in the overtube 60 can be made of a sufficiently
flexible material to allow them to deform when a device or
instrumentation is passed through them. The overtube 60 depicted in
FIG. 5 has a break 40 that is similar to the break 40 depicted in
FIG. 4.
[0048] FIG. 6 depicts a cross-section taken normal to the long axis
of the same embodiment of the overtube 60 as shown in FIG. 5. The
channels 65 in this FIG. 6, however, have been expanded by the
passage of a device 70 or instrumentation. As depicted, the
expansion of the channels 65 can cause a deformation of the
overtube 60 that increases the separation of the break 40.
[0049] FIG. 7 depicts a cross-section taken normal to the long axis
of another embodiment of an overtube 75. In this depicted
embodiment instead of a break, the embodiment has a joint 80 that
can be opened and closed (in one embodiment resealed) multiple
times. The joint can be similar to those found on resealable
plastic bags commonly referred to as zip-lock seals. FIG. 8 shows a
detail view of one embodiment that comprises a resealable joint 80.
The depicted joint 80 is made up of two members: the upper member
85 and the lower member 90. The depicted lower member 90 has a
cross-section in a mushroom profile. The depicted upper member 85
has a circular profile that can snap over the mushroom profile. The
sealed nature of this joint can be preferable for some overtube
applications for instance when the space between an overtube and an
endoscope must maintain a vacuum or set pressure.
[0050] FIG. 9 is a perspective view of the distal end of a
segmented overtube 20 with filler portions between segments removed
for illustrative purposes. Overtubes of the present invention can
be segmented to provide flexibility so that the overtube can more
easily follow a curved path taken by a flexible endoscope. In one
embodiment, segmentation can be accomplished by alternating
sections of a semi-rigid material 95, with flexible filler sections
105 (see FIG. 10). The channels 45, 50 and 55 of an overtube can be
continuous and can run the full length of the overtube 20. The
break 40 also can run the full length of the overtube and can be
present in each semi-rigid section 95. To accommodate the
controlled bending at the tip of an endoscope, a highly flexible
section 100 of the overtube 20 can be present at its distal end.
This flexible tip section 100 can also have a break 40. In one
embodiment the semi-rigid sections 95 can be preferably molded or
extruded from without limitation, a plastic material such as
polypropylene, polyurethane, nylon, polyethylene terephthalate,
polytetrafluoroethylene (PTFE), or silicone, a metal material such
as nitinol or stainless steel, or a plastic material reinforced
with a metal material.
[0051] The channels can be extruded from a plastic material,
preferably with good strength and a low coefficient of friction,
and in one embodiment may be coated with Teflon.RTM. for superior
frictional properties. The flexible tip section 100 can be molded
from an elastomeric material such as, without limitation, silicone.
As will be understood by one of ordinary skill in the art, a number
of other materials can be appropriate for use in the flexible
portions of the presently disclosed devices.
[0052] FIG. 10 is the same perspective view as in FIG. 9 but with
the flexible filler sections 105 present. In one embodiment the
flexible filler sections 105 can be bonded or attached to the
semi-rigid sections 95 and flexible tip section 100 to form a
unitary structure. If the sections 95, 100 and 105 are unitized as
an assembly, the break 40 can be made through the flexible tip
section 100 and all the flexible filler sections 105 at once and in
line with the breaks 40 in individual semi-rigid sections 95.
[0053] FIG. 11 is a perspective view of an introducer 15 positioned
on a flexible endoscope 1 to ease the process of installing an
overtube onto the endoscope. The blade 110 on the depicted
introducer has a thin end 115 and a thick end 120. The thin end 110
can have a thickness about equal to or slightly less than the width
of the break 40 in an overtube. The overtube can be easily slipped
onto the thin end 115 of the introducer blade 110. The overtube can
then be advanced along the length of the introducer and pressed
towards the endoscope shaft. As the introducer blade 110 gradually
widens towards its thick end 120 the overtube is elastically
deformed and the break 40 is opened to a dimension that allows the
overtube to accept the endoscope within the inner perimeter of its
wall. While the introducer described provides a beneficial feature,
they are not required as it is anticipated that the overtube could
also be manually placed or snapped onto an endoscope without the
aid of an introducer.
[0054] FIGS. 12 and 13 provide perspective views of one embodiment
of a clamp mechanism 25 that can secure an overtube 20 to an
endoscope 1 so that their relative positions remain stable during
use. The clamp mechanism may comprise a clamp body 125 that can be
integral with the proximal portion or end of an overtube 20. A
pivoting tee-bolt 135 can be constrained within the clamp body 125.
A clamp nut 130 can engage with the threads of the pivoting
tee-bolt 135. As shown in FIG. 12, the clamp nut 130 can be
threaded out and the pivoting tee bolt 135 can be free to move. The
overtube could be installed in this configuration so the break 40
is free to open and snap over the endoscope 1. When it is desired
to fix the relative positions of the overtube and the endoscope, in
one embodiment the clamp 25 can be locked as shown in FIG. 13. To
lock the clamp, the pivoting tee-bolt 135 can be rotated over and
the clamp nut 130 can be tightened so that the clamp body 125
squeezes the overtube and endoscope and the resultant frictional
force holds the overtube in place.
[0055] FIG. 14 provides three perspective views of the assembly
sequence of a pre-placed device 160 with a further embodiment of an
overtube 140 of the present invention. A pre-placed device is a
device that is placed over an endoscope prior to the start of a
procedure. In practice, the pre-placed device generally may be
fixed near the proximal end of an endoscope where it will initially
not enter the body cavity. Pre-placed devices can be used with
overtubes of the present invention to achieve a variety of
functions including, without limitation, providing a space to
adjust the distance of the endoscope tip to tissue, detecting
changes in tissue (including, without limitation macro- and or
microstructural, biochemical or molecular changes), providing a
space to aspirate and hold tissue, providing a medium to enhance
optics, deploying a stent, deploying a ligating element (including,
without limitation a band or a loop), deploying a cutting
instrument (including, without limitation, a snare or a needle
knife) with diathermy (the use of electrical current as a cutting
device or to stop bleeding during surgery), deploying a cutting
instrument without diathermy, deploying an anchoring or joining
element (including, without limitation, a stitch, staple, or
T-tag), and deploying tissue ablative energy (including, without
limitation, thermal, photochemical, laser, microwave and
radiofrequency). It should be understood that a number of devices
and procedures can be adapted for use as (or with) pre-placed
devices of the present invention. Non-limiting examples include
tools and methods similar to those shown in U.S. Pat. No. 6,953,430
(pincer like instruments for use with an endoscope); U.S. Pat. No.
6,966,906 (deflection instrument for a surgical instrument used
with an endoscope); U.S. Pat. No. 6,206,904 (foreign body recovery
device); U.S. Pat. No. 5,683,413 (forceps for use with an
endoscope); U.S. Pat. Nos. 6,258,083; 6,174,307; 6,902,526; and
U.S. Patent Application No. (USPAN) 20050182298 (tissue ablation
procedures); USPAN 20060058703 (optical biopsy instrument); USPAN
20060047279 (polypectomy snare); and USPAN 20060030756 (vein
harvesting tools). As will be understood by one of ordinary skill
in the art, these functions, devices and methods can be performed
alone or in appropriate combinations, such as, without limitation,
deploying a band or snare after aspirating and holding tissue.
[0056] In one embodiment, the pre-placed device can be protected
with a covering that can maintain the cleanliness or sterility of
the pre-placed device. The coverings according to the present
invention can adopt many different forms including, without
limitation, easily removable bag-type coverings, protective foam
coverings or rigid or semi-rigid plastic coverings. Generally, an
endoscopist will select and install a pre-placed device around an
endoscope based on the type of intervention he/she expects to
perform during a procedure. If the particular intervention is not
required, the pre-placed device can be removed from the endoscope
after the procedure and may be reused at a later time.
[0057] When the endoscopist determines that he/she will use a
pre-placed device during a procedure, an overtube 140 can be
partially installed on the endoscope as described earlier. FIG. 14a
illustrates a section of overtube 140 on the endoscope 1 near a
pre-placed device 160. Pre-placed devices used in accordance with
the present invention may require actuation by the endoscopist to
perform its intended function. Provision for actuation of a
pre-placed device can be made with a control wire 155 that passes
through a channel that runs the full length of the overtube 140 and
terminates in a control device manipulated by the endoscopist. The
overtube 140 has a break 40 running its full length as previously
described to allow installation of the overtube on the endoscope.
In one embodiment, the overtube and pre-placed device can be
connected by way of a bayonet joint. In this embodiment, the
overtube can have a reduced perimeter portion 150 with one or more
lugs 145. The lugs 145 can engage slots 165 in the pre-placed
device 160. Thus, a push and twist action can connect the overtube
and pre-placed device securely. Visible in FIG. 14a are eyelet
recesses 170 that will be described more completely with regard to
FIG. 17. FIG. 14b shows the bayonet joint partially made: the
pre-placed device 160 and the overtube 140 have been pushed
together. In FIG. 14c, the pre-placed device 160 has been twisted
relative to the overtube 140 and the bayonet joint has been
secured.
[0058] FIG. 15a is a perspective view detail of the distal end of
an overtube 140. Bayonet lugs 145 are visible protruding from a
reduced perimeter portion 150. The distal end of the control wires
155 are provided with hooks 175. In this figure two control wires
are illustrated; in practice any number of control wires from zero
to as many as three or four or more could be implemented. The
control wire 155 can run through the channel 180 in the overtube
140.
[0059] FIG. 15b is an end view of the distal end of the overtube
140. Section 16-16 is taken through this view and is shown in FIG.
16. The control wire 155 and its channel 180 in the overtube 140
are shown in FIG. 16.
[0060] FIG. 17a depicts an end view of an assembly of pre-placed
device 160 and overtube 140 as shown in FIG. 14c. The inside
surface 195 of the pre-placed device 160 is shown in the drawing.
Section 17b-17b is taken through the view in FIG. 17a and is shown
in FIG. 17b. FIG. 17b illustrates how the control wires 155 in
overtube 140 can be connected to actuator members 190 in pre-placed
device 160. An eyelet 185 integral with the actuator member 190 can
be engaged by the hook end 175 of control wire 155 when the
pre-placed device 160 and overtube 140 are pushed together and
twisted relative to each other to form a bayonet joint. The eyelet
recess 170 (also visible in FIG. 14a) allows room for a protruding
hook end 175 of control wire 155 to sweep through an arc as the
pre-placed device 160 and overtube 140 are twisted together. Also
shown in FIG. 17b is a channel 200 in the pre-placed device for
actuator member 190. Break 40 and inside surface 195 of the
pre-placed device are also indicated. The engagement of the hook
end 175 of the control wire 155 with the eyelet 185 allows
transmission of tension and compression loads through the control
wire 155 to the actuator member 190 in a pre-placed device.
Uni-directional twisting action of the control wire 155 may also be
transmitted through the junction of the hook end 175 with the
eyelet 185.
[0061] FIG. 18 illustrates an embodiment of a pre-placed device
with a bayonet joint. In the depicted embodiment, the pre-placed
device is a cap intended to act as either a spacer to either
maintain an appropriate distance of the endoscope tip from tissue,
enable the focus of endoscope optical elements, or act as a spacer
for aspiration and retention of tissue to be resected, ligated,
stitched, stapled or ablated. FIG. 18a is a perspective view
illustrating the pre-placed cap device 205 mounted on an endoscope
1. A section of overtube 140 with provision for a bayonet joint
connection is shown in position on the endoscope 1. Bayonet lugs
145 on the overtube 140 are aligned with bayonet slots 165 on the
pre-placed cap 205. The pre-placed cap 205 and overtube 140 are
then pushed together and twisted relative to each other to make the
bayonet connection. FIG. 18b is a detail perspective view of the
pre-placed cap 205 and overtube 140 once connected. The inner
volume 210 of the pre-placed cap 205 is visible in this drawing. By
relative motion of the endoscope and the overtube, the size of the
inner volume may be adjusted.
[0062] FIG. 19 illustrates another embodiment of a pre-placed
device with a bayonet joint. This depicted pre-placed device can be
used to place ligatures around tissue and generally are known as
band ligators. FIG. 19 shows a sequence of three perspective views
detailing the assembly and use of the pre-placed band ligating
device 215. FIG. 19a illustrates the pre-placed band ligating
device 215 positioned on the endoscope 1. The pre-placed band
ligating device 215 may be preloaded with one or more, two or more,
three or more, four or more, five or more, or six or more elastic
ligatures 220 that are stretched to a much larger perimeter than in
their free state. In one embodiment, about six ligatures can be
pre-loaded onto a pre-placed device. FIG. 19a also shows a section
of the overtube 140 in position on the endoscope 1 and in close
proximity to the pre-placed band ligating device 215. FIG. 19b
shows the overtube 140 and pre-placed band ligating device 215
assembled together by actuation of the bayonet joint as previously
described. FIG. 19c shows the pre-placed band ligating device 215
in a typical operational position near the distal end of the
endoscope 1. The control wire 155 has been actuated by the
endoscopist in order to advance a ligature 220 off the end of the
pre-placed band ligating device 215. A deployed ligature 225 in its
much smaller free state is shown.
[0063] FIG. 20 illustrates another embodiment of a pre-placed
device. In this depicted embodiment, the pre-placed device can be
used to place expanding stents inside strictures, such as, without
limitation, in the esophagus. FIG. 20 shows a sequence of three
perspective views detailing the assembly and use of the pre-placed
stent delivery device 230. FIG. 20a illustrates the pre-placed
stent delivery device 230 positioned on the endoscope 1. The
pre-placed stent delivery device 230 is preloaded with an expanding
stent 235 that is constrained to a small perimeter by an
over-wrapping thread or sheath. FIG. 20a also shows a section of
the overtube 140 in position on the endoscope 1 and in close
proximity to the pre-placed stent delivery device 230. Control
wires 155 with hook ends 175 are also shown. The control wires can
be used to initiate and control the expansion of the stent once
properly positioned within a body cavity. With multiple control
wires 155 it can be possible to more accurately control the
expansion of the stent. For example, if two control wires 155 are
used, expansion of the stent can be initiated from both its
proximal and distal ends simultaneously or in sequence. This is in
contrast to the current art in esophageal stent expansion in which
expansion is only initiated from one end. Also in contrast to the
current state of the art, placement of the stent can be done under
endoscopic viewing rather than by fluoroscopic visualization. It is
anticipated that much more accurate and rapid positioning of the
stent at the stricture can be possible under endoscopic viewing.
FIG. 20b shows the overtube 140 and pre-placed stent delivery
device 230 assembled together by actuation of the bayonet joint as
previously described. FIG. 20c shows the pre-placed stent delivery
device 230 in a typical operational position near the distal end of
the endoscope 1. The control wires 155 have been actuated by the
endoscopist in order to deploy the expanding stent 235. As the
stent is expanded, the endoscope 1, overtube 140 and pre-placed
stent delivery device 230 are retracted from the stricture site. A
deployed stent 240 in its expanded free state is shown in position
at the stricture site.
[0064] It is to be understood that the present invention is not
limited to the particular embodiments, materials, and examples
described herein, as these can vary. It also is to be understood
that the terminology used herein is used for the purpose of
describing particular embodiments only, and is not intended to
limit the scope of the present invention. It must be noted that as
used herein and in the appended claims, the singular forms "a,"
"an," and "the" include the plural reference unless the context
clearly dictates otherwise. Thus, for example, a reference to "a
receiving facsimile device" or "a document" is a reference to one
or more receiving facsimile devices or documents and includes
equivalents thereof known to those skilled in the art and so
forth.
[0065] Unless defined otherwise, all technical terms used herein
have the same meanings as commonly understood by one of ordinary
skill in the art to which this invention belongs. Specific methods,
devices, and materials are described, although any methods and
materials similar or equivalent to those described herein can be
used in the practice or testing of the present invention.
* * * * *